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Amylin: Diabetes treatment Byetta worked in clinical trials without other drugs

By Terri Somers

UNION-TRIBUNE STAFF WRITER

1:37 p.m. December 6, 2007

Amylin Pharmaceuticals said Thursday that a clinical trial showed people with adult-onset diabetes taking only the company's drug Byetta were able to lower their blood sugar.

The San Diego company said it plans to use the results of the 232-patient clinical trial to seek approval from the Food and Drug Administration for use of Byetta as a stand-alone therapy.

Currently the drug is approved for use by diabetics who are also taking other drugs, such as metformin, to help control their blood sugar.

Shares jumped more than $1 yesterday, but analysts were mixed as to whether Byetta sales would also jump if it is sold as a stand-alone therapy. Shares closed at $38.72, up $1.14.

When Byetta was approved in April 2005 for use with other diabetes drugs, the FDA sent Amylin a letter saying the drug could receive approval for use as a stand-alone therapy if the company could submit clinical data supporting that.

The company had not sought a promise of such an approval, so Amylin was thrilled.

In the ensuing trial to collect that data, people received either two injections per day of Byetta, or a placebo. Some patients received two doses of 5 micrograms of Byetta per day, while others were given 10 micrograms twice a day. The patients had not previously used diabetes drugs.

About 60 percent of those diabetics were able to lower their blood sugar to the goal level set by the American Diabetes Association. Those receiving the drug also lost weight. One reported side effect was nausea.